Quality Lead Specialist - Regulatory Affairs

GE HEALTHCARE•Waukesha, WI

About The Position

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launches, premarket submissions/registrations, and postmarket compliance, working closely with global healthcare regulatory bodies. Demonstrates an in-depth understanding of key business drivers and uses this knowledge to accomplish assigned work. Exhibits a strong understanding of how the team’s work integrates with other functions and contributes to the broader organization.

Requirements

Bachelor’s degree from an accredited university or college (or a high school diploma/GED with at least 6 years of experience in the relevant job family/function).
At least two years of relevant experience in Regulatory Affairs.

Nice To Haves

Strong oral and written communication skills
Demonstrated ability to analyze and resolve problems
Ability to document, plan, market, and execute programs
Established project management skills

Responsibilities

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launches, premarket submissions/registrations, and postmarket compliance, while collaborating with global healthcare regulatory bodies.
Develops in-depth expertise within the discipline; applies prior experience and acquired knowledge to execute functional policy and strategy.
Communicates with colleagues and the business regarding design and coordination activities. Provides informal guidance to new team members and explains complex information in straightforward scenarios.
Impacts projects, processes, and procedures within own field. Operates with some autonomy, focusing on execution and the provision of guidance within established functional practices and procedures. Activities require professional judgment and may involve occasional guidance from more senior team members.
Utilizes technical expertise and judgment to solve problems. Applies analytical thinking and leverages multiple internal resources, including those outside the immediate team, to support decision-making.